AzTrials
AzTrials

Alopecia AreataPhase 4NCT03473600

Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation

A Phase 4 study testing Cryotherapy and Triamcinolone acetonide injection in people with Alopecia Areata, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Alopecia areata is the most frequent cause of inflammation-induced hair loss with prevalence from 0.1 to 0.2%. It has no age nor sex predilection . Clinically, alopecia areata presents as a well-circumscribed patch of sudden hair loss. It affects any hair bearing area. The most common affected site is the scalp. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Alopecia Areata
What is being tested?
Cryotherapy and Triamcinolone acetonide injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
Nov 2018to Sep 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age >12 years.
  • Both sexes will be included.
  • Newly diagnosed cases.

Who cannot join

  • Children < 12 years.
  • Pregnancy and lactation.
  • Patients with active scalp infection.
  • Patients with cold sensitivity (regarding the first group).
  • Any newly onset medical systemic illness.

Trial locations and contacts

1 site in 1 country.

Hanan Ahmed Morsy, Assistant professor contact

01064447881

Hanan_morsy2003@yahoo.com

Aya Youssef Mohamed, Lecturer contact

01013244819

Aya_badran@yahoo.com

Egypt1 site
  • Faculty of medicine

    Asyut, 71111

    Aya Youssef, Lecturer, 01013244819

Other trials in Egypt

About this study

Official title: Cryotherapy Versus Intralesional Corticosteroid Injection In Treatment Of Alopecia Areata: Trichoscopic Evaluation

Alopecia areata is the most frequent cause of inflammation-induced hair loss with prevalence from 0.1 to 0.2%. It has no age nor sex predilection .

Clinically, alopecia areata presents as a well-circumscribed patch of sudden hair loss. It affects any hair bearing area. The most common affected site is the scalp. Based on site and extent, AA can be classified into; diffuse, multi-locularis, mono-locularis, totalis, universalis, and ophiasis.

Read the detailed description

Histologically, lesional biopsies of alopecia areata demonstrate a peri_follicullare and intra_folliculare mononuclear cell infiltrate around anagen phase hair follicles .The infiltrate consists mostly of activated lymphocytes in particular CD4 cells as well as dendritic cells and macrophages.

Many theories were implicated in pathogenesis of alopecia areata such as; autoimmune lymphocytic attack of the hair, genetic basis and environmental factors. So the pathogenesis of alopecia areata remains to be determined. Currently a widely accepted theory is the autoimmune etiology. Specific T_cell lymphocytes, autoantibodies against anagen follicles, and various cytokines such as interferon-γ, interleukins, and tumor necrosis factor-α have been found to play a major role in alopecia areata. In addition, the immune privilege theory has been recently introduced and suggested to play a role in the pathogenesis.

Many kinds of treatment modalities are present in localized alopecia areata. Injectable forms of corticosteroids are first line of alopecia areata therapy, and also topical use of steroids is widely used. Others are topical sensitization with anthrain, minoxidil and cryotherapy. In extention form of alopecia areata, systemic treatments like corticosteroids, cyclosporine and methotrexate can be used.

Intralesional Corticosteroid injection:

National Guidelines from British Association of Dermatologists, recommend intralesional corticosteroid therapy as the first line treatment for localized patchy alopecia areata, with approximate success rates of 60-75%. Their use was first described in 1958, with the use of hydrocortisone.

Immunosuppression is the main mechanism of action. Corticosteroids suppress the T-cell-mediated immune attack on the hair follicle. Steroids with low solubility are preferred for their slow absorption from the injection site, promoting maximum local action with minimal systemic effect. The efficacy of intralesional corticosteroid injection is variable depending on the patient population treated.

Cryotherapy:

Cryotherapy may act through either singly or by a combination of the following mechanisms resulting in hair regrowth in alopecia areata. After initial vasoconstriction with cryotherapy, there is a significant local vasodilatation during the thaw period as the temperature reaches zero degree Celsius. Thus, cryotherapy is speculated to dilate the vessels around the affected hair follicles, with an increase in the blood flow leading to follicular hair regrowth. Moreover, local edema and inflammation occurring after cryotherapy may play a role in inducing vasodilation.

Cryotherapy is also speculated to inflict partial damage to keratinocytes, especially the antigenic components of the hair follicle keratin16 and trichohyalin, which are targeted by antibodies and thus, further decrease in damaging perifollicular infiltrate.

Cryotherapy may also alter tissue Langerhans cells, which in turn could alter the process of antigen presentation with further decrease in T cell infiltration. As it is known, the white hairs are spared in alopecia areata; it is hypothesized that melanocytes may have a role in the pathogenesis ofalopecia areata. Hence, cryotherapy may also act by destructing the melanocytes further preventing their role in the initiation of alopecia areata.

Dermoscopy:

Dermoscopy is now considered as a valuable tool in diagnosis of variable skin lesions. It is a non-invasive procedure which was initially used to assess pigmented lesions.

Scalp dermoscopy (Trichoscopy) does not only facilitate diagnosis of hair disorders but also give clues about disease stage and progression. Trichoscopy allows the superimposition of the skin layers with the possibility to observe any surface or deep skin layers.

The most common trichoscopic features of alopecia areata are yellow dots, micro-exclamation mark hairs, tapered hairs, black dots, broken hairs, and regrowing upright or regrowing coiled hairs. Black dots as remnants of exclamation mark hairs or broken hairs provide a sensitive marker for disease activity as well as severity of alopecia areata. Yellow dots, are considered to be the most sensitive dermoscopic feature of alopecia areata. Tapering hair is considered as a marker of disease activity and known to reflect exacerbation of disease. Trichoscopic characteristics have a clinical significance in alopecia areata for diagnosis and prognosis.

Severity of alopecia tool Score:

National Alopecia Areata Foundation working committee has devised "Severity of Alopecia Tool score. Severity of alopecia tool score is useful to find out the quantitative assessment of scalp hair loss.

Conditions
Alopecia Areata
Being tested
Cryotherapy, Triamcinolone acetonide injection
Medical subject headings
Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CryotherapyProcedure or surgery

    Liquid Nitrogen spray

  • Triamcinolone acetonide injectionDrug

    Intralesional Triamcinolone Acetonide injection

Study groups in NCT03473600
Study groupRoleWhat they receive
study groupExperimental•The first group (20 patients) will be treated with cryotherapy using liquid nitrogen spray, two cycles each one 3-5 seconds, one session every two weeks, for three months.
Receives: Procedure: Cryotherapy
control groupActive comparator•The second group (20 patients) will be treated with intralesional injection of 4mg/ml/ session of triamcinolone-acetonide, it will be injected into deep dermis or upper subcutaneous tissue using a 0.5-inch long 30-gauge needle at multiple sites, 1 cm apart and 0.1 ml into each site, once every three weeks, for three months, using insulin syringes.
Receives: Drug: Triamcinolone acetonide injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of patietns with hair regrowth

    measuring severity of alopecia tool score and dermoscopic examination

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2018
  2. Study startNov 2018 (estimated)
  3. Primary completionJul 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03473600
Sponsor's protocol ID
CVILCsAA
Status last verified
Mar 2018
First submitted
15 Mar 2018
Last updated
22 Mar 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010 Feb;62(2):177-88, quiz 189-90. doi: 10.1016/j.jaad.2009.10.032.

    PubMed 20115945
  • Campos-do-Carmo G, Ramos-e-Silva M. Dermoscopy: basic concepts. Int J Dermatol. 2008 Jul;47(7):712-9. doi: 10.1111/j.1365-4632.2008.03556.x.

    PubMed 18613881
  • Chang KH, Rojhirunsakool S, Goldberg LJ. Treatment of severe alopecia areata with intralesional steroid injections. J Drugs Dermatol. 2009 Oct;8(10):909-12.

    PubMed 19852119
  • Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med. 2012 Apr 19;366(16):1515-25. doi: 10.1056/NEJMra1103442. No abstract available.

    PubMed 22512484
  • Gilhar A, Paus R, Kalish RS. Lymphocytes, neuropeptides, and genes involved in alopecia areata. J Clin Invest. 2007 Aug;117(8):2019-27. doi: 10.1172/JCI31942.

    PubMed 17671634
  • Gregoriou S, Papafragkaki D, Kontochristopoulos G, Rallis E, Kalogeromitros D, Rigopoulos D. Cytokines and other mediators in alopecia areata. Mediators Inflamm. 2010;2010:928030. doi: 10.1155/2010/928030. Epub 2010 Mar 11.

    PubMed 20300578
  • Inui S, Nakajima T, Itami S. Significance of dermoscopy in acute diffuse and total alopecia of the female scalp: review of twenty cases. Dermatology. 2008;217(4):333-6. doi: 10.1159/000155644. Epub 2008 Sep 18.

    PubMed 18799878
  • KALKOFF KW, MACHER E. [Growing of hair in alopecia areata & maligna after intracutaneous hydrocortisone injection]. Hautarzt. 1958 Oct;9(10):441-51. No abstract available. German.

    PubMed 13610145
  • Kang H, Wu WY, Lo BK, Yu M, Leung G, Shapiro J, McElwee KJ. Hair follicles from alopecia areata patients exhibit alterations in immune privilege-associated gene expression in advance of hair loss. J Invest Dermatol. 2010 Nov;130(11):2677-80. doi: 10.1038/jid.2010.180. Epub 2010 Jul 8. No abstract available.

    PubMed 20613773
  • Madani S, Shapiro J. Alopecia areata update. J Am Acad Dermatol. 2000 Apr;42(4):549-66; quiz 567-70.

    PubMed 10727299
  • Mane M, Nath AK, Thappa DM. Utility of dermoscopy in alopecia areata. Indian J Dermatol. 2011 Jul;56(4):407-11. doi: 10.4103/0019-5154.84768.

    PubMed 21965849
  • Olsen EA, Hordinsky MK, Price VH, Roberts JL, Shapiro J, Canfield D, Duvic M, King LE Jr, McMichael AJ, Randall VA, Turner ML, Sperling L, Whiting DA, Norris D; National Alopecia Areata Foundation. Alopecia areata investigational assessment guidelines--Part II. National Alopecia Areata Foundation. J Am Acad Dermatol. 2004 Sep;51(3):440-7. doi: 10.1016/j.jaad.2003.09.032. No abstract available.

    PubMed 15337988
  • Pimentel CB, Moraes AM, Cintra ML. Angiogenic effects of cryosurgery with liquid nitrogen on the normal skin of rats, through morphometric study. An Bras Dermatol. 2014 May-Jun;89(3):410-3. doi: 10.1590/abd1806-4841.20142249.

    PubMed 24937813
  • Rodriguez TA, Duvic M; National Alopecia Areata Registry. Onset of alopecia areata after Epstein-Barr virus infectious mononucleosis. J Am Acad Dermatol. 2008 Jul;59(1):137-9. doi: 10.1016/j.jaad.2008.02.005. Epub 2008 Mar 7.

    PubMed 18329131
  • Rudnicka L, Olszewska M, Rakowska A, Slowinska M. Trichoscopy update 2011. J Dermatol Case Rep. 2011 Dec 12;5(4):82-8. doi: 10.3315/jdcr.2011.1083.

    PubMed 22408709

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cryotherapy and Triamcinolone acetonide injection in people with Alopecia Areata, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hanan Ahmed Morsy, Assistant professor (01064447881, Hanan_morsy2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of patietns with hair regrowth (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473600, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in